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The overall hypothesis of this study is that subtle interactions between structural (substrate) and functional (trigger) abnormalities of the heart, some of which are genetically-determined, can be used to identify patients at high risk of sudden cardiac death (SCD). Such information may be used to better define patients most likely to benefit from replacement of an internal defibrillator (ICD). The prospective, observational study to enroll, categorize and follow patients who receive an ICD pulse generator replacement for primary prevention of SCD (PROSe-ICD) was established to :

to gain a better understanding of the biological mechanisms that predispose to SCD

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Ages Eligible for Study:

18 Years to 85 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Patients with ischemic or non-ischemic cardiomyopathy undergoing their first ICD generator replacement for primary prevention.

Criteria

Inclusion Criteria:

History of acute MI at least 4 weeks old

Non-ischemic LV dysfunction for at least 9 months

Who have an EF < or = to 35%

Undergone first ERI generator replacement of an FDA-approved ICD for primary prevention of SCD within 12 months of enrollment

Exclusion Criteria:

ICD generator replacement for secondary prevention

Inability or unwillingness to provide valid informed consent

New York Heart Association Class IV heart failure

Patients with pre-existing Class 1 indications for pacemaker therapy.

CRT-D devices.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733590